This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild, moderate, severe renal impairment and subjects with kidney failure compared to the matched control subjects with normal renal function.
This is an open-label, single-dose Phase I study that evaluate the pharmacokinetics, safety, and tolerability of a single dose of DBPR108 100 mg in subjects with mild, moderate, and severe renal impairment (RI), subjects with kidney failure and the control subjects with normal renal function. This study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 3), and a follow-up call on Day 6. Subjects will be enrolled in the following groups: Estimated glomerular filtration rate (eGFR) will be calculated based on Modification of Diet in Renal Disease (MDRD) equation at screening. (A) mild renal impairment (60 ≤ eGFR≤ 89 mL/min/1.73m2); (B) moderate renal impairment (30 ≤ eGFR≤ 59 mL/min/1.73m2); (C) severe renal impairment (15 ≤ eGFR≤ 29 mL/min/1.73m2); (D) kidney failure (\<15 mL/min/1.73m2, not on hemodialysis); (E) control subjects with normal renal function will be matched with subjects with HI by weight, age, and sex (eGFR≥90 mL/min/1.73m2). Approximately 8 subjects will be enrolled in each group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Drug: DBPR108, tablet, oral
First Affiliated Hospital of Soochow University
Suzhou, China
The pharmacokinetic parameters of DBPR108 in plasma
Cmax
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108 in plasma
AUC0-t
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108 in plasma
AUC0-inf
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108 in urine
Ae
Time frame: predose and 48 hours after dosing
The pharmacokinetic parameters of DBPR108 in urine
fe
Time frame: predose and 48 hours after dosing
The pharmacokinetic parameters of DBPR108 in urine
CLR
Time frame: predose and 48 hours after dosing
The pharmacokinetic parameters of DBPR108 in plasma
Tmax
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108 in plasma
t1/2
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
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The pharmacokinetic parameters of DBPR108 in plasma
Vz/F
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108 in plasma
CL/F
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108 in urine
Ae(t1-t2)
Time frame: predose and 48 hours after dosing
The number of volunteers with adverse events as a measure of safety and tolerability
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: Day 1 to Day 6